What is the purpose of the partial cycle of sterilization confirmation run?
The sterilization confirmation part of the cycle is to assess resistance between iPCD and EPCD products. Through some cycles, it is necessary to achieve EPCD resistance greater than or equal to IPCD resistance greater than the product. Where the product requires sterility testing, IPCD should be partially positive to confirm the resuscitation of BI.
What is the purpose of the half-cycle of the sterilization confirmation run?
The sterilization confirmation half-cycle is one of the methods specified in IS011135 to meet SAL=10-6. In the half-cycle, if all IPCD is negative, the time to double is the full cycle, which can ensure that the reproducibility requirements of SAL=10-6 triplicate test are met.
What is the purpose of the full cycle of the sterilization confirmation run?
The whole cycle is set by the upper limit of the parameters of the sterilization process or the daily parameters, so the challenge is the physical and chemical properties of the product; In particular, we sterilize the sample after one of the sterilizations for a second time. The purpose is to challenge the feasibility of secondary sterilization, and the number and method of product performance test items in the whole cycle are carried out by the customer himself, and we do not prescribe it. In particular, it should be noted that the EO ECH test is time-limited, and if the test is commissioned, it needs to be transported on dry ice, and the laboratory should also keep it in dry ice when opening the package.
The sterilization process of medical devices generally includes the following steps:
Pretreatment: Clean, disinfect and other pre-treatment of medical devices to prepare for sterilization.
Sterilization operation: According to the specific sterilization method, the sterilization operation of medical devices is carried out.
Sterilization effect test: The effect test of sterilized medical devices is carried out to ensure the effectiveness of the sterilization process.
Packaging and storage: Sterilized medical devices are packaged and stored to maintain their sterility.
The timing of the entire process depends mainly on the size of the equipment and the complexity of the process. Typically, a typical process can be completed in about 3-5 months!
It should be noted that this is only an approximate timeline, and the specific situation needs to be determined according to the actual equipment and process.
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